Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
FDA drug recalls in 2026
Every FDA drug recall initiated in 2026, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
563 recalls, newest first.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
0.45% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Icosapent Ethyl Capsules
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Class II · Moderate risk
Semaglutide-Glycine-Cyanocobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Lack of Assurance of Sterility
Class II · Moderate risk
SLMD Benzoyl Peroxide Acne Lotion
Chemical contamination: Presence of benzene
Class II · Moderate risk
SLMD BP Acne Spot Treatment
Chemical contamination: Presence of benzene
Class II · Moderate risk
HydroPeptide CLEAR ALLIANCE SERUM
Chemical contamination: Presence of benzene
Class II · Moderate risk
FHF Farmhouse Fresh
Chemical contamination: Presence of benzene
Class II · Moderate risk
Artificial Tears Sterile Lubricant Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Sterile Eye Drops Soothing Tears
Lack of Assurance of Sterility
Class II · Moderate risk
Sterile EYE DROPS REDNESS LUBRICANT
Lack of Assurance of Sterility
Class II · Moderate risk
Sterile Eye Drops ORIGINAL FORMULA
Lack of Assurance of Sterility
Class II · Moderate risk
Ultra Lubricating Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Dry Eye Relief Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
EYE DROPS Advanced Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Sterile EYE DROPS AC
Lack of Assurance of Sterility
Class II · Moderate risk
Product label: Temozolomide Capsules
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Class I · High risk
Webcol Alcohol Prep pad
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
Class II · Moderate risk
Children's Ibuprofen Oral Suspension
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Class II · Moderate risk
Levothyroxine Sodium Tablets USP 150 mcg
Subpotent Drug
Class II · Moderate risk
Tirzepatide Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Inj.
Lack of Assurance of Sterility